|
Device | Sprint Quattro Lead, Y Adaptor/Extender |
Generic Name | Permanent defibrillator electrodes |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P920015 |
Supplement Number | S258 |
Date Received | 08/04/2021 |
Decision Date | 08/19/2021 |
Product Code |
NVY |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Implementation of incoming inspections of silicone rubber tubing received at Medtronic Rice Creek facility to replace inspections no longer occurring at MECC. |